Cyclophosphamide and Rabbit Antithymocyte Globulin (rATG)/Rituximab in Patients With Systemic Lupus Erythematosus
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ClinicalTrials.gov Identifier: NCT00278538 |
Recruitment Status :
Completed
First Posted : January 18, 2006
Results First Posted : February 28, 2020
Last Update Posted : February 28, 2020
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Tracking Information | ||||
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First Submitted Date ICMJE | January 15, 2006 | |||
First Posted Date ICMJE | January 18, 2006 | |||
Results First Submitted Date ICMJE | November 18, 2019 | |||
Results First Posted Date ICMJE | February 28, 2020 | |||
Last Update Posted Date | February 28, 2020 | |||
Actual Study Start Date ICMJE | September 23, 2005 | |||
Actual Primary Completion Date | December 2018 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
Survival [ Time Frame: 6 months, then yearly x 5 years after transplant ] The primary efficacy outcome is overall survival.
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Original Primary Outcome Measures ICMJE |
The primary efficacy outcome is overall survival and the proportion of participants who achieve and maintain remission after transplant. Remission is defined according to the RIFLE as duration on no immune suppressive medications except physiologic doses | |||
Change History | ||||
Current Secondary Outcome Measures ICMJE | Not Provided | |||
Original Secondary Outcome Measures ICMJE | Not Provided | |||
Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Cyclophosphamide and Rabbit Antithymocyte Globulin (rATG)/Rituximab in Patients With Systemic Lupus Erythematosus | |||
Official Title ICMJE | Cyclophosphamide and rATG/Rituximab in Patients With Systemic Lupus Erythematosus: Phase II Trial | |||
Brief Summary | This study is designed to examine whether treating patients with lupus with high dose cyclophosphamide together with rATG/rituximab (drugs which reduce the function of the immune system), followed by return of their previously collected stem cells will result in improvement in the disease. Stem cells are undeveloped cells that have the capacity to grow into mature blood cells, which normally circulate in the blood stream. The purpose of the intense chemotherapy is to destroy the cells in the immune system which may be causing this disease. The purpose of the stem cell infusion is to produce a normal immune system that will no longer attack body. The study purpose is to examine whether this treatment will result in improvement in the lupus disease. | |||
Detailed Description | Mobilization Participants will be administered Cyclophosphamide at 2.0 g/m2 in 200 ml of normal saline (NS) over 1 hour. Hydration with 0.9 NS at approximately 100-250-ml/ hour will begin 4 hours prior to cyclophosphamide and continued for 24 hours after termination of cyclophosphamide. Urine output approximately greater than 100 ml/hour should be maintained. Granulocyte-colony stimulating factor (G-CSF) will be administered subcutaneously at 5-10 mcg/kg/day and will be started 5 days after termination of cyclophosphamide administration. After the absolute neutrophil count is greater than 1000/ul or after hematological nadir, leukapheresis using a continuous flow blood cell separator will be initiated. A 10-15 liter apheresis will be performed unless stopped earlier for clinical judgment of toxicity (e.g., numbness, tetany). The G-CSF will continue until apheresis is discontinued. If necessary, platelets will be transfused to greater than 60,000/ul prior to each apheresis. Conditioning Regimen Mesna: 50mg/kg/day x 4 days will be given intravenously over 24 hours. Cyclophosphamide: 50 mg/kg/day x 4 days (the lesser of ideal or actual weight) will be given intravenously over 1 hour in 250 cc of normal saline on days -5 through -2. Hydration: approximately 50-200cc/hour in adults should begin 6 hours before cyclophosphamide and continue until 24 hours after the last cyclophosphamide dose. Hydration rates need to be individually adjusted by daily weights to maintain dry weight count. Twice daily weights will be obtained. Warning: Participants with renal insufficiency are prone to volume overload. Early institution of ultrafiltration or dialysis is recommended. rATG 0.5mg/kg will be given IV on day -5, 1.0mg/kg will be given on day -4, 1.5mg/kg will be given IV on days -3, -2, -1 (no dose adjustment). It will be given over 10 hours. Premedicate with Solumedrol 250mg IV, acetaminophen 650mg po qd and diphenhydramine 25mg 30 minutes before infusion. Rituximab 500mg/day will be given IV on days -6 and +1. At the first dose (D-6), rituximab infusion will be started at 50mg/h and escalate the infusion rate by 50mg every 30minutes to a maximum of 400mg/h. Starting the second dose (days -4, -2 and +1). IV infusion will be started at 100mg/h and escalate the infusion rate 100mg every 30minutes to a maximum of 400mg/h. Premedicate with Solumedrol 250mg IV, acetaminophen 650mg po qd and diphenhydramine 25mg 30 minutes before infusion on days -6 and +1. Premedicate acetaminophen 650mg po qd and diphenhydramine 25mg 30 minutes before infusion on days -4 and -2. Stem Cell Reinfusion Previously collected stem cells will be reinfused on day 0 as noted in Table 4. The stem cells are infused over approximately 20 minutes through the central venous catheter, such as a peripherally inserted central catheter (PICC line). Following stem cell reinfusion, routine daily labs will be obtained including complete blood count (CBC), chemistry panel, and liver function tests. Antibiotics and blood transfusions will be administered as required by clinical judgment. |
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Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 2 | |||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Systemic Lupus Erythematosus | |||
Intervention ICMJE | Biological: Hematopoietic stem cell transplantation
Autologous hematopoietic stem cell transplantation
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Study Arms ICMJE | Experimental: Hematopoietic Stem Cell Transplant Regimen 2
Autologous Hematopoietic Stem Cell Transplantation: Rituximab, rATG and Cyclophosphamide regimen
Intervention: Biological: Hematopoietic stem cell transplantation
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
32 | |||
Original Enrollment ICMJE |
20 | |||
Actual Study Completion Date ICMJE | May 2019 | |||
Actual Primary Completion Date | December 2018 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 15 Years to 60 Years (Child, Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00278538 | |||
Other Study ID Numbers ICMJE | DI SLE.Auto2003 | |||
Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Current Responsible Party | Richard Burt, MD, Northwestern University | |||
Original Responsible Party | Not Provided | |||
Current Study Sponsor ICMJE | Northwestern University | |||
Original Study Sponsor ICMJE | Same as current | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Northwestern University | |||
Verification Date | November 2019 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |